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Informed Consent Form for Platelet Rich Plasma Injections: Evidence-based and Legally Guide for Orthopaedic Surgeons

Abstract

Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons' defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

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PMID: 39859067 PMC: 11767021. DOI: 10.3390/medicina61010084.

References
1.
Vithran D, Xie W, Opoku M, Essien A, He M, Li Y . The Efficacy of Platelet-Rich Plasma Injection Therapy in the Treatment of Patients with Achilles Tendinopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2023; 12(3). PMC: 9918262. DOI: 10.3390/jcm12030995. View

2.
Harnett J . Research Ethics for Clinical Researchers. Methods Mol Biol. 2021; 2249:53-64. DOI: 10.1007/978-1-0716-1138-8_4. View

3.
Gupta A, Jeyaraman M, Potty A . Leukocyte-Rich vs. Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis. Biomedicines. 2023; 11(1). PMC: 9856144. DOI: 10.3390/biomedicines11010141. View

4.
Tonge X, Crouch-Smith H, Bhalaik V, Harrison W . Do we achieve the Montgomery standard for consent in orthopaedic surgery?. Br J Hosp Med (Lond). 2021; 82(4):1-7. DOI: 10.12968/hmed.2020.0504. View

5.
Kaux J, Croisier J, Leonard P, Le Goff C, Crielaard J . Exuberant inflammatory reaction as a side effect of platelet-rich plasma injection in treating one case of tendinopathy. Clin J Sport Med. 2013; 24(2):150-2. DOI: 10.1097/JSM.0b013e31829aa410. View